Safety and Efficacy Study of Icotinib With Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma

April 16, 2018 updated by: Haihua Yang, Taizhou Hospital

Phase Ⅰ/Ⅱ Study of Icotinib Hydrochloride Combined With Intensity-modulated Radiotherapy in Nasopharyngeal Cancer

Nasopharyngeal carcinoma (NPC) is a prevalent disease in southeast of China. Radiation therapy with or without chemotherapy is a standard therapy for nasopharyngeal cancer. Cytotoxic chemotherapy plays an important role in the curative treatment of advanced NPC. However, concurrent chemoradiotherapy increased significantly local and systemic toxic effects, which may preclude many patients from proceeding with combined therapy. The epidermal growth factor receptor(EGFR) gene is amplified in 40% and EGFR protein is overexpressed in over 80% of NPC. EGFR overexpression is also associated with shorter survival following chemoradiotherapy in locoregionally advanced NPC. And some basic researches have proved that EGFR tyrosine kinase inhibitors(TKIs) could increase the radiosensitivity and reduce the epithelial-mesenchymal transition (EMT) in NPC cell line. Moreover, distant metastases has been the major cause of treatment failure in NPC. Icotinib hydrochloride is a novel oral EGFR TKIs with low mammalian toxicity(made in China). But base on toxic effects of Icotinib, it may increase toxic effects about skin and mucosa in combination therapy with Icotinib and Intensity-modulated Radiotherapy (IMRT). The prospective study will assess the tolerability and efficacy of Icotinib combined with IMRT in patients with NPC. This regimen is of great interest and it has potential to alleviate the adverse effects, improve patient compliance and better therapeutic ratio.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Taizhou, Zhejiang, China, 317000
        • Taizhou Hospital, Wenzhou Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with histological proof of squamous carcinoma of the nasopharynx.
  2. Patients must have ECOG Performance Status of 0-1.
  3. Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of >/= 1500 cells/mm3, platelet count of >/= 100,000 cells/mm3; adequate hepatic function with bilirubin </= 1.5mg/dl, AST and ALT </= 2x the upper limit of normal; serum creatinine </= 1.5mg/dl, creatinine clearance >/= 50 ml/min and INR 0.8 - 1.2.
  4. Patients must sign a study specific informed consent form prior to study entry.

Exclusion Criteria:

  1. Evidence of metastases by clinical or radiographic examinations.
  2. History of malignancy other than non-melanoma skin cancer.
  3. Prior chemotherapy or anticancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region except for radioactive iodine therapy.
  4. Patients with uncontrolled intercurrent disease.
  5. Patients with currently active malignancy.
  6. Pregnant or lactating women Female patients of childbearing potential who are unwilling to practice adequate contraception during study treatment and for two months after the last administration of study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase I: the maximum tolerated dose of Icotinib in combination with IMRT for NPC
Time Frame: 30 days
30 days
Phase II: 2 years locoregional control rate
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
The overall response rate (complete and partial response)
Time Frame: 1 month following treatment and then every 3 months
1 month following treatment and then every 3 months
The acute and late toxicity profile associated with the study regimen
Time Frame: 1 month following treatment and then every 3 months
1 month following treatment and then every 3 months
The duration of control of locoregional disease
Time Frame: 1 month following treatment and then every 3 months
1 month following treatment and then every 3 months
Overall survival, disease-free survival, and distant relapse rates
Time Frame: At time of locoregional disease progression
At time of locoregional disease progression
EGFR status in tissue and blood before treatment
Time Frame: 2 week of pretreatment
2 week of pretreatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taizhou Hospital

Investigators

  • Study Director: Haihua Yang, MD., Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
  • Study Chair: Wei Hu, MD., Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
  • Principal Investigator: Wei Wang, BS, Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
  • Principal Investigator: Chao Zhou, MD., Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 13, 2012

First Submitted That Met QC Criteria

February 15, 2012

First Posted (Estimate)

February 16, 2012

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YHH-201201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nasopharyngeal Carcinoma

Clinical Trials on Icotinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe